BEUDAMED
    41 results · 11ms · Sources: EU EUDAMED, US FDA

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    LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·February 24, 2016

    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKB·August 11, 2009

    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DLZ·August 11, 2009

    DIST LAT FEM LOCK PLT, RT

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    DIST LAT FEM LOCK PLT, LT

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·January 8, 2014

    PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 10, 2008

    SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 47235700518 47235700604 47235700606 47235700608 47235700610 47235700612 47235700614 47235700618 47235700706 47235700708 47235700710 47235700714 47235700808 47235700810 47235700814 47235700906 47235700908 47235700914 47235700918 47235701006 47235701008 47235701010

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 13, 2019

    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 26, 2015

    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired

    FDA Recall
    Terminated ·KT Health, LLC·Product code IME·September 16, 2019

    KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT-D Size 5, 10-0004, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009